Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano announced the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization for international execution of Study SP-03-B101. The move follows recent regulatory approvals supporting study expansion and marks the transition of the Sapu003 program from an Australia-based clinical effort toward a broader multinational development strategy, including planned expansion into Europe.
SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The company said GCT has already completed key regulatory submissions ahead of schedule and initiated clinical operations, site activation and study management activities. Sapu003 is an intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle(TM) platform, which is designed to improve drug delivery and provide more predictable systemic exposure than oral administration while supporting future global registrational studies.
This expansion is significant because Sapu003 addresses a key limitation of oral everolimus—variable absorption and exposure—by providing an intravenous formulation with more consistent pharmacokinetics. The Deciparticle platform enables targeted delivery and potentially reduces side effects, which could improve patient outcomes and expand the therapeutic window. The appointment of GCT, a global CRO with expertise in multinational trials, accelerates the path to potential registration in multiple regions. For patients with advanced mTOR-sensitive solid tumors, this program offers hope for a more effective and better-tolerated treatment option.
The multinational strategy, including planned European expansion, also positions Oncotelic to leverage regulatory pathways that may allow for faster approvals. The company’s CEO, Dr. Vuong Trieu, holds over 75 issued patents and has filed more than 500 patent applications, indicating a strong intellectual property foundation. Oncotelic also utilizes its proprietary AI-enabled PDAOAI platform for research and regulatory processes. Beyond its internal pipeline, Oncotelic holds a 45% interest in GMP Bio, a joint venture advancing complementary therapeutic candidates.
For investors, this development signals a step forward in Oncotelic’s clinical execution capabilities. The timely regulatory submissions by GCT demonstrate momentum, and the expansion into Europe could open larger patient populations and commercialization opportunities. The full press release is available at https://nnw.fm/olX92. More information about Oncotelic is available in the company’s newsroom at https://nnw.fm/OTLC.
